Development and Validation of Stability-indicating Reverse Phase HPLC Assay for Tramadol in Bulk and Tablet Formulations

DOI:

https://doi.org/10.37285/ijpsn.2019.12.3.5

Authors

  • Pankaj Padmakar Nerkar
  • Vaishali Badjuar
  • Pradyum Ige
  • Hitendra Mahajan
  • Sameer Ansari

Abstract

This manuscript describes the development and validation of a simple, isocratic, and accurate reversed-phase HPLC method for the assay of tramadol in bulk powder form and tablet formulations. The chromato-graphic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5μm) column using acetonitrile: methanol: phosphate buffer pH 3.4 adjusted with orthophosphoric acid: (20:10:70, v/v) as a mobile phase, at a flow rate of 1 mL/min and detection at 271 nm. The linear range for tramadol were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.999. The retention time was found to be 4.47 min for tramadol that was subjected to stress conditions, such as hydrolysis, oxidation, photolysis and thermal degradation, and the stressed samples were analyzed using the above methodology. The method was validated for the precision, accuracy, linearity and robustness. The developed stability-indicating method for tramadol was validated as per ICH guidelines.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Tramadol, Stability indicating method, RP-HPLC method, Validation, ICH

Downloads

Published

2019-05-31

How to Cite

1.
Nerkar PP, Badjuar V, Ige P, Mahajan H, Ansari S. Development and Validation of Stability-indicating Reverse Phase HPLC Assay for Tramadol in Bulk and Tablet Formulations. Scopus Indexed [Internet]. 2019 May 31 [cited 2024 May 20];12(3):4544-52. Available from: http://ijpsnonline.com/index.php/ijpsn/article/view/301

Issue

Section

Research Articles

References

Bakshi M and Singh S (2002). Development of validated stability-indicating assay methods, critical review. J Pharm Biomed Ana, 28: 1011-1040.
Belal T, Awad T and Clark R (2009). Determination of paracetamol and tramadol hydrochloride in pharmaceutical mixture using HPLC and GC-MS. J Chroma Sci, 47: 849-854.
Biradar S, Kalyankar T, Wadher S, Moon R. and Dange S (2014). Stability indicating HPLC method development: review. Asian J Med Anal Chem, 1: 21-26.
Blessy M, Pate L R D, Prajapati P N and Agrawal Y (2014). Development of forced degradation and stability indicating studies of drugs: A review. J Pharm Analysis 4: 159-165.
Cione A P, Tonhi E and Silva P (2011). Stability indicating methods. Q C of herbal medicines and related areas. InTech, 25e36.
Desai P, Captain A and Kamdar S (2012). Development and Validation of HPTLC Method for Estimation of Tramadol HCl in Bulk and in Capsule Dosage Form. Int J Pharm Tech Res 4: 1261-5.
Gogulamudi L and Sujana K (2012). Development and validation of UV Spectroscopic method for determination of Tramadol Hydrochloride in bulk and formulation. Inter J of Pharm and Pharma Sci, 4: 275-279.
Kamble RM and Singh SG (2012). Stability-indicating RP-HPLC method for analysis of paracetamol and tramadol in a pharmaceutical dosage form. J Chem 9: 1347-1356.
Kartinasari WF, Palupi T and Indrayanto G (2004). HPLC determination and validation of tramadol hydrochloride in capsules. J Liq Chrom & Related Tech 27: 737-744.
Karunakaran K, Navaneethan G and Elango K (2012). Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of paracetamol, tramadol HCl and domperidone in a combined dosage form. Trop JPharm Res, 11: 99-106.
Manikandan K, Kathiravan S, Varatharajan P, Sabarikumar K, Karuppasamy C and Radhakrishnan K (2012). Development and Validation of Tramadol Hydrochloride bulk and solid dosage form by RP-HPLC method. Inter J Bioand Pharm Res 3: 245-251.
Patel J and Patel P (2014). RP-HPLC Method Development and Validation for the Estimation of Diclofenac Sodium, Tramadol Hydrochloride and Chlorzoxazone from their Combined Tablet Dosage Form. Inter J Pharm and Pharma Sci, 6: 22-29.
Rao BV, Sowjanya GN, Ajitha A and Rao VUM (2015). A review on stability indicating HPLC method development. World J Pharm and Pharma Sci, 4: 405-423.
Sagarbechara S, Prabhu PP, Subrahmanyam E, Kaneria J J, Saparia S and Shabaraya A (2013). Development of New Analytical Method and its Validation for the Determination of Tramadol Hydrochloride in Bulk and Marketed Formulations. Asian J Biomand Pharma Sci 3: 53-61.
Snyder LR, Kirkland JJ and Glajch J L (2012). Practical HPLC Method Development, John Wiley & Sons.

Most read articles by the same author(s)